effects of novel flash glucose monitoring system on glycemic control in adult patients with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: this trial is a randomized, multi-center, parallel-group, efficacy and safety study with a 26-weeks follow- up(after 2-week recruitment). the study aims to: 1)compare the effects of novel flash glucose monitoring system (fgms) and conventional self measurement of blood glucose (smbg); and 2) optimize integrated management for glycaemic control in adult patients with type 1 diabetes who are sub-optimally controlled.

subjects with type 1 diabetes who meet criteria will be enrolled at up to eight clinical research sites in china. subjects will be randomized to either flash glucose monitoring system(freestyle libre®;abbott diabetes care,witney, oxon,uk) or conventional self measurement of blood glucose (bayer®)alone at least three times per day. primary outcome variable is the difference in hba1c which will be analyzed in a central laboratory between baseline and the 26weeks follow-up. secondary outcome variables such as time-in-range, frequency and duration of and hyperglycemic episodes etc. will be assessed at baseline (week 0 to 2), week 12-14 and week 24-26 via professional continuous glucose system (ipro2®; medtronic). at the same time, demographic factors, clinical data, patient reported outcome (pros) will be collected. assessment of adverse events will occur via self-reporting at each visit and/or phone call. all patients will receive same ordinary diabetes education.

Eligibility criteria:
inclusion criteria: 1. aged 18 years and older; 2. diagnosed with type 1 diabetes with the criteria established by who in 1999,with duration more than 1 year; 3. glycosylated hemoglobin a1c concentration between 7% and 10%; 4. self-monitor of blood glucose levels on a regular basis for 2 months previous( at least 3 times per day) and have willing to insist for at least 6 months 5. using csii or mdi for at least 3 months, stable diabetes medication regimen for 3 months prior to study entry(change in insulin ≦20%). 6. willing to wear cgm; 7. able to speak, read, and write chinese exclusion criteria: 1. having used cgm 3 months prior to study entry; 2. had severe diabetic complications such as pdr in diabetic retinopathy and esrd of diabetic nephropathy, assessed by investigators; 3. receiving oral steroid therapy for any disorders and continuous use of paracetamol. 4. had known allergy to medical-grade adhesives or cgm and its affiliated components; 5. being pregnant or planning pregnancy (as demonstrated by a positive test at study entry); 6. recent severe diseases like myocardial infarction,stroke,psychiatric diseases(historical/recent),malignant tumor, kidney disease(defined as egfr\<45), dermatosis, decided by investigator. 7. current participation in another investigational study (must have completed any previous studies at least 30 days prior to being enrolled in this study); 8. currently abusing illicit drugs, alcohol, or prescription drugs; 9. any condition that could impact reliability of the hba1c measurement,（e.g.hemoglobinopathy, hemolytic anemia, chronic liver disease),decided by investigator.

Keywords: flash glucose monitoring system fgms